BioPharma Drug Approval
CSL Vifor and Travere Therapeutics Secure Swissmedic Approval for FILSPARI in Treatment of IgA Nephropathy
CSL Vifor and Travere Therapeutics, announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults w...
October 18, 2024 | News
Antengene’s XPOVIO® Gains Third Approval in South Korea for Multiple Myeloma Treatment
This approval for XPOVIO® for the treatment of patients with multiple myeloma (MM) marks the third approved indication of the drug in South...
October 18, 2024 | News
Dizal Receives Fourth Breakthrough Therapy Designation for Sunvozertinib in EGFR Exon20ins NSCLC
Fourth Breakthrough Therapy Designation for sunvozertinib in NSCLC with EGFR exon20ins Dizal (SSE:688192), a biopharmaceutical company committed to d...
October 14, 2024 | News
Genentech's Itovebi™ Wins FDA Approval for HR-Positive Breast Cancer, Doubling Progression-Free Survival in PIK3CA-Mutated Cases
– Approval is based on Phase III INAVO120 results, showing the ItovebiTM (inavolisib)-based regimen more than doubled progression-free sur...
October 11, 2024 | News
Telix Pharmaceuticals Secures TGA Approval for Illuccix® to Select Patients for PSMA-Targeted Radionuclide Therapy
Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Australian Therapeutic Goods Administration (TGA) has approved the us...
October 08, 2024 | News
Ascentage Pharma’s APG-2449 Tyrosine Kinase Inhibitor Cleared for Two Registrational Phase III Studies in NSCLC Patients
Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet med...
October 08, 2024 | News
Akeso's Cadonilimab Gains Approval for First-Line Treatment of Advanced Gastric Cancer in China
Akeso (9926. HK) announced that its internally developed PD-1/CTLA-4 bispecific antibody, cadonilimab, has received approval from the National Medical Prod...
October 01, 2024 | News
BioCity Biopharma's SC0062 Receives Breakthrough Therapy Designation from NMPA for Treatment of IgA Nephropathy
BioCity Biopharma (BioCity) announced its endothelin receptor type A (ETA) selective antagonist SC0062 has been granted the Breakthrough Therapy Desig...
September 27, 2024 | News
Innovent Biologics' New Drug Application for Picankibart Accepted by China's NMPA for Treatment of Moderate to Severe Plaque Psoriasis
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality me...
September 27, 2024 | News
Nuance Pharma Expands Bentrio® Nasal Spray Launch in Asia, Files for Mainland China Approval
Nuance Pharma successfully launched Bentrio® nasal spray for protection against airborne particles in Hong Kong and filed request for ...
September 24, 2024 | News
Antengene Secures Thailand FDA Approval for XPOVIO®: The First and Only XPO1 Inhibitor in the Market
XPOVIO® is the first and only approved XPO1 inhibitor in Thailand. XPOVIO® has been approved for multiple indicatio...
September 24, 2024 | News
CD Biopharma Receives FDA Clearance for IND Application of CD-001, Paving the Way for Phase I Clinical Trial
CD (Suzhou) Biopharma has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application...
September 23, 2024 | News
Singapore Becomes First Southeast Asian Market to Launch BESREMi®️, Setting a New Standard for Rare Disease Care
PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator specializing in haematology and oncology, proudly announces the launch of BES...
September 17, 2024 | News
FDA Approves Eli Lilly's EBGLYSS™ for Moderate-to-Severe Atopic Dermatitis in Patients Aged 12 and Over
Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved EBGLYSS™ (lebrikizumab-lbkz), a targeted IL-13 ...
September 16, 2024 | Analysis
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